Preventing Anxiety and Depression in Older Hispanics (HOLAA&D)

University of Miami

Status: Active, not recruiting

Conditions: Depression; Anxiety

Treatments: Behavioral: HOLA Component 4; Behavioral: HOLA Component 2; Behavioral: HOLA Component 3; Behavioral: HOLA Component 1; Behavioral: Healthy lifestyles education program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03870360

20180816

R01MD012610 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to look at the best ways to prevent anxiety and depression in older Latino adults who are at risk for developing anxiety and depression. Participants will be randomized to either a health promotion intervention or a healthy lifestyles education program.

Full description

Given the prevalence and morbidity of depression in later life, the inadequacies of current treatment approaches for averting years living with disability, the inequities in access to the mental health care delivery system, and the workforce shortages to meet the mental health needs of older Latinos, development and testing of innovative strategies to prevent depression and anxiety are of great public health significance and have the potential to change practice.

Enrollment: 240 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Latino (self-identified);
• Age 60+;
• Subthreshold depression defined as a score ≥ 5 on the Patient Health Questionnaire (PHQ-9), OR subthreshold anxiety as defined as a score ≥ 5 on the GAD-7;
• Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI);
• Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator;
• Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner;
• Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization;
• Expect to be resident in Miami for the subsequent 2 years.

Exclusion criteria

• Have met criteria for major depressive disorder or generalized anxiety disorder within the past 12 months;
• Have met criteria for alcohol or other substance abuse disorders within the past 12 months;
• Are currently receiving antidepressant medication or participating in other mental health treatment;
• Have a lifetime history of bipolar disorder or other psychotic disorder including major depression with psychotic features;
• Have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam (MMSE) score <24;
• Are current tobacco smokers since smoking influences systemic inflammation;
• Have contraindications to physical activity outlined in the American College of Sports Medicine standards;
• Have high suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire;
• Are unable to complete 10 m walk test;
• Currently residing in a nursing or group home;
• Have a terminal physical illness expected to result in the death within one year;
• Any evidence of current infection; and
• Have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention (further defined in the protocol).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

HOLA: A Culturally-Tailored Health Promotion Intervention

Experimental group

Description:

16 week, multicomponent, health promotion intervention

Treatment:

Behavioral: HOLA Component 1

Behavioral: HOLA Component 3

Behavioral: HOLA Component 2

Behavioral: HOLA Component 4

Healthy lifestyles education program

Active Comparator group

Description:

Educational material on mental health, physical activity, and information on community resources

Treatment:

Behavioral: Healthy lifestyles education program